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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-475-14
Device Problem Activation Failure (3270)
Patient Problems Hemorrhage, Cerebral (1889); Dysphasia (2195); No Known Impact Or Consequence To Patient (2692)
Event Date 06/19/2020
Event Type  Injury  
Manufacturer Narrative
The pipeline flex has not been returned for evaluation; product analysis cannot be performed. The device was not returned; the reported event could not be confirmed. The cause of the event could not be conclusively determined from the reported information. The device involved in this event is not approved in the us; the device's brand name and model number are provided below. This report is being filed against a similar device. Brand name: pipeline flex with shield technology model number: ped2-475-14. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that the medtronic flow diverter did not open distally despite several attempts to open by resheathing. The medtronic flow diverter was replaced with another medtronic flow diverter to complete the procedure. Post procedural angiography showed good stasis in both aneurysms. No patient injury was reported as a result of the event. Prior to the event, approximately ¼ of the medtronic flow diverter was deployed. The medtronic flow diverter did not flare distally so the physician attempted to open it by resheathing it 3-4 times. At this point, the medtronic flow diverter looked abnormal, so a decision was made to remove the entire flow diverter with the microcatheter and replace with new one. The patient was undergoing embolization of a saccular aneurysm measuring 3. 5mm x 3. 2mm located in the pcom origin of the left internal carotid artery (ica). The physician was unsure of the status (if patient had bleed) of the aneurysm. The distal and proximal landing zone was 4. 2mm x 4. 3mm. The patient¿s vasculature was moderate in tortuosity. The patient was on dual antiplatelet therapy. There are no images for review. The medtronic flow diverter was not placed on a bend and no additional steps were taken to attempt to open it.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key10187891
MDR Text Key198142035
Report Number2029214-2020-00589
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-475-14
Device Catalogue NumberPED2-475-14
Device Lot NumberA865240
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/16/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/24/2020 Patient Sequence Number: 1
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